September 24, 2014

In honor of the 30th anniversary of the Drug Price Competition and Patent Term Restoration Act — more commonly known as the Hatch Waxman Act — which enabled manufacturers to bring generic versions of pharmaceuticals to market more easily, GPHA president Ralph Neas issued a statement.

September 24, 2014

In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

May 28, 2014

Actavis on Tuesday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration seeking approval to market saxagliptin hydrochloride tablets, 2.5 mg and 5 mg.

January 31, 2014

Following the announcement that Rep. Henry Waxman, D-Calif., intended to retire, the Generic Pharmaceutical Association bid adieu to a legislator who had a tremendous positive impact on the generic industry.

November 20, 2013

Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 1, 2013

Mylan expects to be the first to market with a generic version of a drug for treating patients with gout, the company said Friday, though its filing has triggered a lawsuit from the makers of the branded version.

October 31, 2013

Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

October 29, 2013

Actavis hopes to become the first company to market a generic version of a drug used to treat acne in adolescents and adults, the company said.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

April 21, 2013

Last month, the Supreme Court heard Federal Trade Commission v. Actavis, which could impact the future of the generic drug industry at a time when 80% of all prescriptions dispensed in the United States are generic.

March 25, 2013

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

March 21, 2013

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

February 28, 2013

It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act.

February 28, 2013

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

January 3, 2013

A court has ruled in favor of Indian generic drug maker Ranbaxy Labs in a case concerning a generic blood pressure drug, the legal firm representing the drug maker said.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

November 29, 2012

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 15, 2012

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.